What We Do – Overview

HM Healthcare Partners is a full-service multi-specialty clinical research firm fundamental to your organization’s growth. We offer our clients breadth and flexibility based on their individual needs. Whether you have an idea for a research project and lack the knowhow to make it a reality or have a product that needs data for claim validation, or no time to write your research grant, or desire to conduct a clinical trial, we possess the ability to realize your goals within your timeline and exact specifications.

Intimate collaborations are very successful in science which is why we work with organizations of all sizes to produce results that are intellectually satisfying. We are committed to upholding the highest ethical standards to ensure the timely delivery of the most accurate, high-quality, up-to-date data.

Our expertise includes:

  • research administration: pre- and post-award services
  • grant proposal development and medical writing
  • budget development, negotiation and reconciliation
  • study design, data collection, maintenance, and record retention
  • protocol development and execution
  • statistical analysis, biostatistics, sampling
  • regulatory compliance and submission
  • human subject recruitment
  • business development and external relationships

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Medical Writing and Grant Development

HM Healthcare Partners maintains a high standard of competence in medical writing so we may provide our clients with high-quality translational deliverables. Our medical writers are proud members of the prestigious American Medical Writers Association (AMWA). We’ve helped our clients develop high-quality deliverables and successfully secure funding of proposals in a number of therapeutic areas including:

  • allergy/immunology
  • asthma
  • atopic dermatitis
  • cardiology
  • heart failure
  • hypertension
  • dermatology
  • endocrinology
  • diabetes
  • gastroenterology
  • inflammatory bowel disease
  • genetics
  • infectious disease
  • HCV
  • HIV/AIDS
  • neurology
  • multiple sclerosis
  • oncology
  • breast
  • CLL
  • bladder
  • colorectal
  • orthopedics
  • pain management
  • pulmonary medicine
  • pulmonary fibrosis
  • public health & prevention
  • rheumatology
  • rheumatoid arthritis

Medical Writing

Medical writing involves the careful dynamic union between scientific medical knowledge along with elements of skill, precision and careful preparation in the production of high-caliber scientific documents. Effective medical writing is brief and well organized in nature. This facet is key in communicating your clinical research ideas and findings to a target audience in a crisp and succinct manner. We have developed many original peer-reviewed scientific context for our clients in wealth of therapeutic areas. Our many years of medical writing experience sets us apart to create well-structured, unbiased documents that comply with industry standards for health care professionals.

Grantsmanship

Grantsmanship is an art form that meticulously balances skill and persuasion. A proposal requires approximately 6- to 9-months of planning and writing prior to the submission (and possibly resubmission) to the supporter. Because grant proposals are highly competitive nature, it is imperative that the proposal is original and creative, show scientific merit, be innovative, literate, focused and well-organized. As broad-based physician-scientists who have achieved a deeper understanding of normal and obtuse functions of grant writing, we epitomize these mechanisms and apply them directly to your proposal to produce an integrated masterpiece.

The increasingly stringent demands of the grant reviewer present superfluous pressure on the writer. Choosing to collaborate with another scientist who shares the same goals, makes it possible to benefit from winning over the review. We are proud to have helped our clients obtain funding from their desired funding source(s) and get their research project(s) underway. Our experience in writing multiple types of winning grant proposals, across the research spectrum lends us the tenacity to write, edit and peer-review your grant proposal.

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Protocol Development

The protocol is a document that details how a clinical trial or study will be conducted. Proper protocol development is the foundation for a successful research study. The document contains pertinent information on the study’s background, rationale, methodology, and a plan to ensure the safety of subjects. HM Healthcare Partners specializes in quality protocol development to your exact specifications. Our strategic design and planning methods always take into consideration important key elements such as sample size, deviations, blinding and randomization procedures while maintaining both the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) recommendations for protocol content.

Our writing services include:

  • regulatory affairs/submission
  • Institutional/Independent Review Board (IRB)
  • data safety monitoring planning
  • protocol development
  • grants management and reporting
  • informed consent forms
  • medical education materials
  • research administration documents
  • peer-review
  • study forms/compliance logs
  • study-wide/baseline forms
  • literature reviews and meta-analysis
  • poster presentations
  • monographs
  • biosketch
  • white papers
  • PowerPoint presentations
  • manuscript development
  • medical writing services in clinical operations and data management
  • grant writing and development (R01, R03, R21, R21/33, SBIR/STTR, NSF, CDC, VA, private, non-profit, industry, CME)

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Project Management

Each project is unique and faces diverse challenges. Project management is a vital facet in the success of research projects through the application and integration of various methods, experience, techniques and competencies employed throughout the project’s life-cycle. Project management entails everything from providing the sponsor with high-quality deliverables, in addition to ensuring the timely and accurate study communications to internal and external personnel.

We have managed all aspects of full-scale and small research projects from start-up to close-out. Our culture and core principles prioritize the importance of project management to achieve the original goals by employing proactive project management processes, setting realistic expectations, effective communication, planning and estimation to deliver the defined project objective(s), right, the first time, on-time.

Our project management services include:

  • sponsor communications
  • budget planning
  • data collection/aggregation
  • liaise collaborative agreements between institutions
  • risk management
  • Institutional/Independent Review Board (IRB)
  • grants management and reporting
  • study monitoring
  • subject recruitment

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Funding Support and Budget Formulation

The budget is the most pivotal component of the research project. It is the portion that gives details how awarded sponsor funds will be used to accomplish the goals of the study. A well-developed budget requires careful planning, consideration, negotiation, management, and analysis. HM Healthcare Partners has aided in the development and considerations for budgets alike and has matched numerous clients with unique funding opportunities. We think outside the box to match you with opportunities that best aligns with the PI’s background, your organization’s tax classification, organizational goals, and the specific aims of the research project to maximize funding opportunities.

Our funding support identification services include:

  • government
  • National Institutes of Health (NIH)
  • Centers for Disease Control and Prevention (CDC)
  • Agency for Healthcare Research and Quality (AHRQ)
  • Patient Centered Outcomes Research Institute (PCORI)
  • Department of Defense (DOD)
  • other federal, state, county agencies
  • foundations, professional societies
  • private/individual donors
  • corporations and industry
  • intramural resources
  • RFP/RFQ identification
  • budget development/negotiation

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Data Management and Processing

Data collection and management is the most critical phase of the research project. The data management process begins with the implementation of regulatory compliant tools that best suit the specific aims and study design to generate high-quality, reliable and accurate data, otherwise known as the data management plan (DMP). The DMP describes the processes with respect to data entry, database design, tracking, quality control, discrepancy, and protection methods.

HM Healthcare Partners understands the importance of maintaining the integrity of captured data. We employ routine monitoring and audits via our quality assurance program to enhance the reliability, validity, and credibility of the data. After the data is collected, it is then synthesized and analyzed for statistical significance (or insignificance) using data processing software such as SPSS.

Our data management and processing services include:

  • biostatistics
  • sampling
  • statistics
  • sample size and power
  • quality control

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Clinical Monitoring

HM Healthcare Partners directly manages complex research studies across a multitude of scientific and therapeutic areas including medical devices, pharmacologic research, behavioral interventions and medical education research. Our monitoring processes include:

  • identification of study specific investigators
  • study staff education
  • site specific qualification, initiation and close out visits.
  • interim site monitoring and safety analysis
  • data query resolution
  • quality control

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Regulatory Services

High quality regulatory management is one of the most important aspects of clinical research. Improper regulatory management can be disastrous not only to the research project but also for the personnel and organization who are in conducting the research. HM Healthcare Partners has decades of experience in both central institutional/independent review boards (IRB) & local IRBs. We specialize in the preparation, submission, maintenance and close-out authorizations with all research governing bodies including the FDA.

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Site Management

HM Healthcare Partners works directly with the study sponsor from start to finish along with your research site to ensure the provisions in the study protocol are being met. HM’s clinical operations team collaborates directly with the site administration and each principal investigator to ensure the study success. Beginning with a site feasibility questionnaire, sites are then selected based upon the parameters reported concurrently with careful consideration of the site’s patient population. Research sites are carefully selected upon demonstration of appropriate infrastructure for the specific studies.

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Quality Assurance

The purpose of quality assurance is to promote excellence in research through the adherence of the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines. We are committed to quality assurance by adhering to our standard operating procedures and implementing our unique auditing approach which ensures the ethical conduct of research. Our many years of experience and commitment to periodic review and orientation allow us to assure the highest quality using a series of internal checklists and forms that enhances the credibility, reliability, and validity of the research. HM’s routine monitoring throughout the project management phase surveys your data to ensure that it reflects the most accurate, up-to-date information and that is in compliance with the study protocol and regulatory requirements.

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Ancillary Services

As a full-service clinical research organization, we are able to provide the following services on an as-needed basis:

  • research coordinator services
  • research associate services
  • study start-up and close-out
  • study monitoring
  • study record retention
  • participant/subject recruitment
  • principle investigator services/locating

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